Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatment glutenfree diet during the first year of life
Sponsor Institut fur Diabetesforschung, Munich, Germany
Start date February 2001
End date December 2009
Trial size 150 participants
Trial identifier NCT01115621, ZI310/14-1

Summary

The major goals of this project are to determine whether primary intervention through delayed introduction of dietary gluten is feasible and could reduce the incidence of islet autoimmunity in high-risk first degree relatives of patients with type 1 diabetes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Glutenfree diet during the first year of life
glutenfree diet during the first year of life
Glutenfree diet during the first year of life
(No Intervention)

Primary Outcomes

Measure
Effect of dietary intervention on the development of islet autoantibodies
time frame: 3 years

Secondary Outcomes

Measure
Effect of dietary intervention on the development of Type 1 diabetes.
time frame: 10 years

Eligibility Criteria

Male or female participants up to 3 months old.

Inclusion Criteria: - Newborn offspring or siblings of patients with type 1 diabetes with a HLA genotype conferring a high diabetes risk Exclusion Criteria: - If infants have an illness or birth defect that precludes long-term follow-up or involves use of treatment that may alter the natural history of diabetes

Additional Information

Official title BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk
Principal investigator Anette G Ziegler, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2010.
Information provided to ClinicalTrials.gov by Institut fur Diabetesforschung, Munich, Germany.